Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

Key facts

Study ID

NCT00690638

Run by

Phenomix

People needed

480

Starts

2008-07-01

Expected to finish

2010-04-01

Last updated by the study team

2010-04-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
• BMI 25 to 48 kg/m2, inclusive
• HbA1c 7.0% - 10.0%, inclusive
• Age 18 to 75 years, inclusive

You may not qualify if…

• Currently on 3 or more oral antidiabetic drugs or insulin.
• Type 1 diabetes mellitus

Where it is running

• Study site — Orange, California, United States
• Study site — Santa Ana, California, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Brockton, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Cincinnati, Ohio, United States
• Study site — El Paso, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Caba, Buenos Aires, Argentina
• Study site — La Plata, Buenos Aires, Argentina
• Study site — Lanus, Buenos Aires, Argentina
• Study site — Paraná, Entre Ríos Province, Argentina
• Study site — Salta, Salta Province, Argentina
• Study site — Rosario, Santa Fe Province, Argentina
• Study site — Corrientes, Argentina
• Study site — Hyderabad, Andhara Pradesh, India
• Study site — Bangalore, Karnataka, India
• Study site — Kalaburagi, Karnataka, India
• Study site — Mumbai, Maharashtra, India
• Study site — Nagpur, Maharashtra, India
• Study site — Norwalk, California, United States

Full record on ClinicalTrials.gov

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